THE PCCA BLOG

We’re Raising the Bar on Quality: PCCA Becomes First to Earn USP Verification for Compounding Bases

Wed, 02 Jul 2025 22:19:00 GMT

At PCCA, we strive to lead through innovation and are defined by our unwavering commitment to quality. That’s why we’re proud to share some exciting news: LoxOral® and Anhydrous SuspendIt®, two of our most widely used proprietary bases, are now part of the U.S. Pharmacopeia (USP) Ingredient Verification Program for Excipients.

We’re honored to be the first FDA-registered supplier to receive USP Verification for compounding bases. We proactively pursued and invested in this program to verify the quality of our bases, even though regulations do not require it. We believe raising the bar on quality isn’t just a choice, it’s a responsibility.

Why USP Verification Matters

USP sets public quality standards that are used in over 140 countries. Earning the USP Verified Mark for Excipients means a product has met USP’s rigorous testing, review and auditing criteria for manufacturing process and quality.

For us, this verification recognition isn’t just a credential — it’s a reflection of who we are. It shows that when we say our bases are trusted quality, consistent and reliable, we have the science and third-party confirmation to prove it.

A Closer Look at Our USP Verified Excipient Bases

Currently, our two USP Verified Excipient bases are:

LoxOral: An all-in-one compounding excipient designed for oral capsules, facilitating the easy mixing of diverse active pharmaceutical ingredients.
Anhydrous SuspendIt: A specially designed, water-free oral base that mixes easily with liquids and offers improved taste and broader applications.

These bases have been trusted by compounding pharmacists for years. Now, they carry the USP Verified Mark for Excipients — offering a new level of confidence for you and your patients.

Proactive, Not Reactive

This achievement reflects our commitment to leading the industry, not just keeping up with it. As our CEO Gus Bassani, PharmD, puts it:

“This validation milestone demonstrates our ‘Quality without Compromise’ core value in action. Confirmation of quality through independent verification reinforces our promise to pharmacies and patients alike. By undertaking this approach, we help our members compound with confidence.”

And we’re not stopping here. We’re actively working toward USP Verification for additional proprietary bases — part of our longstanding investment in research, innovation and raising the bar for quality in pharmaceutical compounding.

What This Means for You

The USP Verified distinction sets PCCA’s products apart, adding a powerful mark of quality to complement the exceptional performance and functionality of our compounding bases. When you choose PCCA, you’re choosing more than a base — you’re choosing trusted quality, scientific rigor and a partner committed to your success.

We’re proud to take this step forward with you, and we’ll continue to lead with integrity, innovation and a focus on what matters most: your ability to serve patients with confidence.

Best Practices for Marketing

Wed, 05 Feb 2025 15:00:00 GMT

Compounding pharmacists offer unique solutions tailored to meet specific patient needs and should have the opportunity to share these options appropriately in their communities. While promoting awareness of compounding services is vital, it’s important to thoughtfully approach how you market the services your pharmacy provides. Poorly executed marketing can attract regulatory and legal scrutiny. As such, it’s essential to understand that all marketing content, including publicly available materials, are subject to review by regulators and legal entities.

Patients, caregivers and healthcare practitioners seeking treatment options may not be familiar with the concept of compounding or the variety of ways compounding pharmacies can address specific healthcare concerns. It’s crucial that patients have access to all available treatment options and that prescribers are aware of and refer patients to compounding pharmacies that adhere with state and federal regulatory agencies. When promoting your compounding pharmacy, keep in mind the following key areas when creating or contracting marketing collateral.

Adhere to Legal and Regulatory Requirements for Compounding

Compounding pharmacists, technicians and marketers must be familiar with the requirements of the state boards of pharmacy where they are licensed. While state boards typically require compliance with the United States Pharmacopeia (USP), it’s important to note that some states may have alternative or more stringent standards. The FDA also provides various guidance documents that compounding pharmacies should be aware of — notably their Insanitary Conditions guidance. The most important aspect of these standards is patient safety. Staying up to date on compounding regulations helps minimize risks to patients and helps compounders avoid marketing noncompliant compounded preparations or practices.
Avoid Unsubstantiated Claims

Under Section 503A of the Food, Drug and Cosmetic Act, compounded human drugs are exempt from the new drug approval process. Because compounded preparations don’t undergo the FDA’s approval process for safety and efficacy, compounders should refrain from making statements suggesting that these preparations are “safe” or “effective.” It’s critical to avoid marketing materials that could be interpreted as making unsupported claims.
Conduct Thorough Marketing Reviews

Whether you choose to outsource marketing or develop materials in-house, it’s essential that all marketing content is reviewed and approved by someone with the necessary expertise. If your organization lacks this expertise, consider partnering with a legal or regulatory professional who can oversee the approval process. This precaution helps prevent potential pitfalls, such as inadvertently making unapproved claims or what may be perceived as a claim.

Resources: Best Practices for Marketing

It’s crucial that both patients and healthcare practitioners understand that compounding exists to address specific and the often-unmet needs of patients. Appropriately communicating compounding services through various marketing channels is essential — but it must be done responsibly.

The Alliance for Pharmacy Compounding (APC) has developed a detailed document outlining best practices for marketing by compounders. While these recommendations are not legal advice, they provide useful guidance to help navigate the creation of marketing materials.

Ensure your practice remains in FDA regulatory compliance by reviewing the FDA Insanitary Conditions guidance.

PCCA members with clinical services access may reach out to our Clinical Services team for help with marketing, as well as with other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

Hazardous Drug Wipe Sampling: Do I have to?

Thu, 05 Dec 2024 21:41:00 GMT

by Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

USP 800 discusses Environmental Quality and Control (Section 6) related to environmental wipe sampling for hazardous drug (HD) surface residue. This is not a requirement in USP 800; instead, it is stated that this should be performed routinely. What does this mean for those who handle HDs and why should compounders consider performing routine HD wipe sampling?

When handling HDs, the goal is to minimize exposure through different containment control strategies, from receiving through administration. Containment controls used in practice can be looked at as a hierarchy, with personal protective equipment (PPE) as the least effective and elimination of the HD as most effective. Elimination of HD handling is not an option in most cases, so one must utilize proper engineering controls such as negative pressure rooms, biological safety cabinets, containment ventilated enclosures and closed system transfer devices.

Other forms of containment controls include proper donning and doffing of PPE and removal of HDs through deactivation, decontamination, cleaning and disinfecting (DDCD). Containment can also be achieved through proper administrative controls such as HD communication, training and assessment of risk. Still, even if you follow all containment strategies, how do you know if they are working and that your staff and patients are not exposed?

HD wipe sampling can determine if your containment control strategies are working properly to reduce the risk of HD exposure to your team in any step of the handling processes.

What and where should I test?

USP 800 recommends HD wipe sampling be performed as a baseline at least every six months. Once you identify the areas to test, wipe sampling is a fairly simple process. It is recommended to test at various locations in your facility, starting from the time the HD enters the facility until the time it leaves. There are several companies that offer a wipe sampling kit. The contents may include a set of instructions, tubes for collection, a template to measure the area for collection and a swab used for sampling in each location. It is important to follow the instructions carefully and properly document the HDs to be tested and the corresponding areas within the facility that were swabbed.

USP 800 states the following areas should be tested when performing wipe sampling; however, it would be best to identify high-touch areas throughout the facility — again, from receiving to dispensing/administration — when possible:

Interior of the C-PEC and equipment contained in it
Pass-through chambers
Surfaces in staging or work areas near the C-PEC
Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging and dispensing area)
Areas immediately outside the HD buffer room or the C-SCA
Patient administration areas

A good place to start is to look at where HDs are handled throughout your facility. In a community pharmacy, this includes areas where patients pick up HD medications. In a health system, consider including medication rooms and patient rooms. Identify locations that have the highest touch rates to determine which areas to sample.

You also need to determine which drugs to test. Depending on the testing company you choose, you can test for a variety of drugs — from antineoplastics to hormones and even drugs such as spironolactone or finasteride. Consider testing for the HD drugs used most frequently in your facility.

What do I do with the sampling results?

Sampling results appear as a quantity if a drug is detected or listed if the drug(s) tested was not detected or present in the area sampled. Some companies color the results if a detected HD is higher than average.

If detectable contamination is found, the designated person is required to identify, document and contain the source of contamination. This can be done by creating an “environmental action plan,” a detailed document that outlines strategies and processes, including actions, timelines, responsible parties and measurable goals. Tracking and trending the wipe sampling results can drive change in your facility to contain the identified HD.

Again, there is not an established action limit for HD contamination levels, so any detectable amount will need to be addressed. Wipe sample results should be used to drive change and improve processes. Changes may include revising the DDCD process, seeking alternatives to HD storage or the use of a closed system transfer device.

Sampling data can be shared with staff to show where HD contamination is working and where it isn’t. Once you start collecting data, you will be able to keep track of sampled locations and start to trend results. The results may never reach zero, but using HD wipe sampling data should lead to a reduction in HD contamination levels.

PCCA members with clinical service access may contact our Clinical Services team for additional information on HD wipe sampling and other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

Reference

United States Pharmacopeia. Online Subscription Required.

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.

The Best Jam Compounding Fest in the Land — Until Next Year!

Wed, 30 Oct 2024 15:00:00 GMT

ThinkNext: International Seminar 2024 (ThinkNext: ISTX24), held October 17 - 19 in Houston, Texas, was a huge success with well over 500 rockstar compounders from around the world. We’re sharing seminar highlights and memorable takeaways that make PCCA members return year after year.

The following summaries, however, do not give justice to the many workshops and presentations offered at ThinkNext: ISTX24. Nor do they capture the energy, networking, educational pearls, laughter and good times shared. You’ve got to be there to fully appreciate and experience the best jam compounding fest in the land.

Clinical Presentations

Compounding Ideas for Dermatology and Wound Care
PCCA Clinical Pharmacist Nat Jones, RPh, FAPC, discussed compounding options for hair growth, ideas for topical anti-aging face formulations and understanding wounds and evaluation options for step-by-step wound care.
Hospice and Palliative Care in Veterinary Medicine
PCCA Vice President of Creative Development Chris Simmons, RPh, and PCCA Clinical Compounding Pharmacist Mark Gonzalez, PharmD, defined hospice and palliative care, described the disease states commonly seen in the veterinary hospice/palliative care setting, shared compounded options and discussed the value compounding brings to this area of veterinary medicine.

Innovation

Behind the Science: PCCA Innovation
PCCA Chief Scientific Officer Gus Bassani, PharmD, and PCCA Director of Research & Development Daniel Banov, RPh, MS, shared new data from scientific studies conducted on EctoSeal P2G ™ and SubMagna™ SL HMW that members can share with prescribers.
Leadership and How to Fail Like a Boss
Keynote speaker Dave Aspery, “the father of biohacking,” pointed out how the five F's: "fear, food, fertility, friends and forgiveness," drive a person's energy, also noting how our life expectancy and longevity are influenced by our physical and mental health.

Marketing

New Trends in Social Media
Magnolia Pharmacy owner and president Steve Hoffart, PharmD, shared tips on how to use social media to market your pharmacy in your community and to federal legislators.
A Practical Approach to AI and How I Use It
Las Colinas Compounding & Wellness Pharmacy’s Stacy Hightower, CPhT, FAPC, discussed game-changing AI and how she develops marketing campaigns, gains consumer insights and increases pharmacy revenue using this powerful tool.

Revenue Generation

Building Supplement Sales
PCCA Director of Member Engagement Erin Michael, MBA, MS, CPhT, FAPC, and PCCA Director of Business Solutions Laura Pfaffenberger, PharmD, discussed market trends for dietary supplements and how to tap into this lucrative niche.
What Is Your Job?
Williamsburg Drug Company owner and pharmacist T.W. Taylor, RPh, shared how consultation services provided by his pharmacy helped his patients restore their health and increase his pharmacy’s revenue.
Business Accelerator: Move Your Pharmacy Forward — Faster
PCCA Director of Business Solutions Laura Pfaffenberger, PharmD, took the stage and announced Business Accelerator, which offers workable solutions that address staffing, operations, strategy and growth specific to compounding pharmacies.

Regulatory Concerns

Implications of Your Marketing from a Regulatory Perspective
PCCA Clinical Services Director Matt Martin, PharmD, BCSCP, and PCCA Director of Member Engagement Erin Michael, MBA, MS, CPhT, FAPC, discussed the regulatory considerations that apply when promoting your practice, best practices for promoting your services without making claims and the standards images should meet before being used in promotional content.
PCCA Public Affairs
PCCA Vice President of Public Affairs, Education and Human Relations Lizzie Harbin opened the Regulatory, Public Affairs and Industry Partner Panel by discussing the importance of advocating for our industry. Lizzie then invited CEO of the Alliance for Pharmacy Compounding Scott Brunner, CAE, and CEO of the National Community Pharmacists Association Doug Hoey, RPh, MBA, to discuss imminent threats to pharmacies: compounding hormones, pharmacy benefit managers (PBMs) and direct and indirect remuneration (DIR) fees, as well as the role of telehealth in pharmacies.

Award-Winning Members

Joseph P. Navarra, RPh, FACA, FAPC, owner of Town Total Compounding Center in Woodbury, New York, and board chair of the Alliance for Pharmacy Compounding, was named PCCA’s 2024 M. George Webber, PhD, Compounding Pharmacist of the Year.
Stacy Hightower, CPhT, FAPC, of Las Colinas Pharmacy Compounding & Wellness in Irving, Texas, owned by Jim and Jan Hrncir, was honored as PCCA’s inaugural Compounding Technician of the Year.
Jerry Beamer, RPh, co-owner of Andrews Apothecary in Winston-Salem, North Carolina, was honored as the recipient of the 2024 L. David Sparks Advocacy Award.
Isha Gupta, PharmD, MBA, owner of HatchRx Compounding Pharmacy in Long Island, New York, was honored as the recipient of the 2024 George Roentsch, RPh, New Innovator Award.

We thoroughly enjoyed rocking out with our PCCA members, sponsors and friends and look forward to seeing more new and familiar faces next year at ThinkNext: International Seminar 2025 — the best jam compounding fest in the land.

USP Chapter 800: Managing HD Spills

Wed, 02 Oct 2024 21:27:53 GMT

by Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

The United States Pharmacopeia (USP) General Chapter 800 addresses the handling of hazardous drugs (HDs) to minimize the risk of exposure to patients, health care workers and the environment. It became compendially applicable in November 2023. USP 800 contains some key elements that specifically apply to employee safety and HD containment. Section 16, for example, discusses managing HD spills and retaining spill kits on site. This article addresses HD spills that occur in a compounding pharmacy; however, it can be adapted for handling of non-HD chemical spills as well.

Spill Control

Team members involved in HD spill cleanup must be properly trained in spill management and the use of appropriate personal protective equipment (PPE), including respirators. Team members qualified in spill control must be available whenever HDs are handled in the pharmacy. Spills must be contained and cleaned immediately by qualified personnel.

Standard operating procedures (SOPs) that address spill management must also be in place. SOPs should include:

How to document HD spills
Personnel responsible for spill management
Prevention of spills
Cleanup of spills
Evaluation of personnel exposed during spills
Size and scope of spills, including capacity of spill kits
PPE (including respirators) and cleanup materials for handling spills
Location of spill kits

Spill Kits

Management and effective cleanup of HD spills require access to appropriate spill kits. Spill kits can be purchased from various vendors; however, it is often easier to make one by using PPE and cleaning materials already onsite. Doing so will allow your pharmacy staff to use properly fitted PPE and familiar cleanup materials.

Prepackaged spill kits often do not contain the correct sizes of PPE required by team members, nor do they have the correct N95 respirators that properly fit staff. Many prepackaged spill kits do not contain deactivating, decontaminating, cleaning and disinfectant cleaners (DDCD), nor do they contain the appropriate number of cleaners for containing a spill. In addition, your staff may not be familiar with the DDCD agents included in the spill kit and, therefore, may require additional training during a spill occurrence.

Creating a spill kit with materials already available in the pharmacy may make it easier, safer and less stressful for your staff to manage an HD spill, especially if HD spills seldom occur. Each spill kit should contain at least:

2 HD gowns
2 pairs of shoe covers
2 pairs of ATSM D6978 appropriately sized gloves
Fit tested N95 respirator (or other appropriate respirator as determined by size and scope of kit)
Low-lint absorbent materials/pads/wipes that may otherwise be used during routine cleaning procedures DDCD cleaner
Sign to notify of HD spill in the area
Container for disposal of HD waste
Eye protection (Please note: Goggles or a full facepiece respirator must be used as eye protection. Eyeglasses or safety glasses with side shields will not adequately protect eyes.)
Disposable scoop and/or shovel for container fragments

PPE sizes can be customized to the specific employees involved in spill management or based on the largest team member’s size.

The spill kit should be stored in a puncture-resistant container or bucket with a cover, so if broken glass or hard plastic fragments are within HD substance spills, all can go into the container for disposal. The container should be clearly labeled as a spill kit on the outside and placed in an easily identified area so all team members know where it’s located. At a minimum, spill kits should be located in areas where chemicals are received and prepared. Spill kits should also be labeled with the item of shortest expiration date on the outside of the kits; that item should be replaced as needed prior to expiration.

Spill Drills

When a liquid or powder HD spill occurs, staff members may feel stressed and unsure of how to handle the spill due to infrequent occurrences.

It’s recommended that staff routinely practice and understand how to handle a spill to reduce stress and potential confusion. Recommendations include:

Spill drills conducted frequently with staff responsible for management of spills
- Create mock HD spill using an inert substance:
  - Baby powder can be used to represent a powder spill
  - Water colored with food color can stand in for a liquid spill
  - Glow powder can be used to show a spill and see if any residue is left behind after following the procedures outlined in the spill kit
- Use spill kit contents to clean up spill
- Documentation of spill drills as part of training
Laminated instructions inside spill kit
- List of “how to” instructions contained within the spill kit
- One team member will clean the spill while another team member calls out step-by-step instructions to guide the cleanup of the spill
Disposal of spill contents
- Disposal of contents of spill contained in bag labeled for hazardous disposal
- Check with your waste disposal company on HD spill disposal procedures
  - Usually disposed of in same manner as other HDs

While USP 800 may not be enforceable in all states, it is important to note that federal agencies, such as the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH) and the FDA, are involved in protecting compounding pharmacy staff from potential exposure to HDs.

Additional information regarding USP 800 is available in the blog: USP 800: Is It Enforceable?

Members with clinical services access may contact our Clinical Services team for help with spill kits and other compounding questions.

References

United States Pharmacopeia. Online Subscription Required.
OSHA. Controlling Occupational Exposure to Hazardous Drugs. Accessed September 2024 at https://www.osha.gov/hazardous-drugs/controlling-occex#resources

The Storied Past of Quinacrine HCI

Wed, 15 May 2024 13:09:50 GMT

As one of the most studied synthetic drugs in modern history, quinacrine HCI was first used as an antimalarial and later to treat rheumatic skin diseases, including lupus. With May designated as Lupus Awareness month, learn more about quinacrine HCI and the twists and turns of its storied past.

Quinacrine hydrochloride (HCI) (atabrine, mepacrine, chinacrin), developed in the late 1920s, was the first synthesized form of quinine — a natural alkaloid isolated from the South American cinchona bark tree that was used for centuries by indigenous people to treat fevers, chills and other malaria-type symptoms.^1-3

During World War II (WWII), quinacrine replaced quinine for use in U.S. soldiers as an antimalarial prophylaxis and to treat soldiers infected with malaria — most notably those stationed in the South Pacific. According to a U.S. Surgeon General Office report, quinacrine was administered to more than three million soldiers. The soldiers were routinely monitored for safety and efficacy, which made quinacrine one of the most extensively studied synthetic drugs in the history of modern medicine.^1,2 The monitoring also led to recognition of symptom relief in soldiers afflicted with differing types of lupus.

It's important to note that quinacrine was not the only drug synthesized from quinine pre- and post-WWII. Chloroquine phosphate was developed in 1934; however, due to an initial evaluation that determined toxicity levels were too high for human use, chloroquine was not used as an antimalarial until after the conclusion of WWII.³ Hydroxychloroquine sulfate, developed in the 1950s to reduce the toxicity of chloroquine, is another synthesized form.⁴

Chloroquine phosphate and hydroxychloroquine sulfate are substituted 4-amino quinoline compounds that differ only by a hydroxy group. Quinacrine hydrochloride also has the 4-amino quinoline radical but has, in addition, a benzene ring; it is classified as an acridine compound.⁵

Collectively, antimalarials quinacrine, chloroquine and hydroxychloroquine were studied throughout the decades following WWII. Although the mode of action remains disputed, the antimalarials would ultimately gain recognition as effective treatments for systemic lupus erythematosus and cutaneous lupus erythematosus.^1-4

Types of Lupus: Systemic & Cutaneous

An autoimmune disease, where a person’s immune system attacks healthy tissue, lupus often causes pain and inflammation in any part of an afflicted person’s body. In addition to affecting skin and joints, lupus can also affect internal organs. Lupus primarily affects women, with onset generally occurring between ages 15 – 45.

Systemic lupus erythematosus (SLE) is the most prevalent form of lupus. Although symptoms vary among individuals, typical symptoms include arthritis; fevers; fatigue; a malar or “butterfly” rash that appears across the nose and cheeks; hair loss; sensitivity to the sun; swollen glands; swelling in the legs or around the eyes; pain when breathing deeply or lying down; headaches, dizziness, depression, confusion or seizure; and abdominal pain. Inflammation caused by SLE can led to damage in internal organs, including kidney failure (lupus nephritis); seizures and memory problems; heart valve damage due to scarring, inflammation of the lining around the heart muscle (pericarditis) and inflammation of the heart muscle itself (myocarditis); inflammation of blood vessels (vasculitis); blood clots due to high levels of antiphospholipid antibodies; low blood cell counts; and inflammation of tissue that surrounds the lungs (pleurisy).⁶

Cutaneous lupus erythematosus (CLE) primarily affects the skin and is composed of three main types: acute cutaneous lupus (acute skin lupus), subacute cutaneous lupus (subacute lupus) and chronic cutaneous lupus (discoid lupus), the latter of which is the most common type.7 Discoid lupus appears on the scalp or in the bowl of the ear as a red to purple rash that causes discoloration, scarring and hair loss. Although CLE primarily affect the skin, providers are advised to closely monitor patients to ensure the disease does not affect internal organs.⁸

Quinacrine HCI: First Use in Lupus Treatment

In October 1951, Francis Page reported in Lancet his observations on the treatment of 18 cases of lupus erythematosus with quinacrine HCI at daily doses ranging from 100 to 300 mg. Of the 18, 14 patients showed good or excellent improvement of skin lesions. Three patients showed slight improvement, while one patient had no visible change.⁹

The success of quinacrine HCI spurred others to conduct similar studies. In 1953, Bernard L. Rhodes, M.D., and Manuel F. Allende, M.D., reported before the California Medical Association that 25 patients with chronic discoid lupus erythematosus were administered 100 mg. of quinacrine HCI three times daily for two to three weeks, followed by 100 mg. daily until satisfactory results were obtained. Twenty-one of the 25 patients showed satisfactory improvement, seven of whom had complete clearing of lesions. The remaining four did not improve.¹⁰

Throughout the following decades, quinacrine HCI — often compounded with hydroxychloroquine or chloroquine — remained a standard treatment for SLE and CLE.^1-6

DQSA Regulation

Section 503A and 503B of the Drug Quality and Security Act (DQSA) establish criteria for bulk drug substances used in the respective compounding environments. FDA has also issued interim policies while they work to finalize lists of bulk substances for 503A and 503B; items that appear on Category 1 of the interim lists may be eligible for enforcement discretion until the FDA issues a final rule on those items. In 2016, PCCA nominated quinacrine HCI for inclusion on the 503A Bulks List. However, during the FDA evaluation process, several FDA Divisions and Committees, including the Pharmacy Compounding Advisory Committee (PCAC) and the Office of New Drugs (OND), raised safety concerns about quinacrine HCI. Remarkably, the OND advised that “although quinacrine might be safe at the 100 mg/day dose prescribed for rheumatic skin diseases, generalists might prescribe the drug at higher doses and for alternative indications that were not formally studied.” As a consequence, the PCAC voted against adding quinacrine to the 503A Bulks List. However, FDA ultimately placed quinacrine HCI on Category 1 with a restriction, “(except for intrauterine administration),” allowing for oral use in compounded preparations by 503A compounding pharmacies. FDA also placed quinacrine HCl on the 503B Category 1 interim bulks list with the restriction “for oral use only.”^11,12

FDA Acceptance

The FDA proposed a final rule for the inclusion of quinacrine HCI in March 2021 to the 503B Bulks List for oral dosage forms, stating “it meets a clinical need for patients with CLE…and has a long history of use in compounding, in addition to a significant body of literature demonstrating its potential effectiveness for the treatment of patients with CLE.”¹¹ The FDA added quinacrine HCI — for oral use only — to the 503B Positive Bulks List on April 6, 2023.¹³To date, the FDA has not issued a rule for quinacrine in 503A pharmacies; as such, quinacrine HCI remains part of the interim policy.

Listen as PCCA Vice President of Clinical Services, A.J. Day, PharmD, discusses the return of quinacrine HCI for patient care on the Mortar & Pestle podcast.

References

Kumar, M., Sarkar, A.( 2022) Repurposing of Anti-Malarial Drug Quinacrine for Cancer Treatment: A Review. Scientia Pharmaceutica.; 90(1):12. Accessed May 2024 at https://doi.org/10.3390/scipharm90010012
Kalia, S., Dutz, J. P. (2007). New concepts in antimalarial use and mode of action in dermatology. Dermatologic therapy, 20(4), 160–174. Accessed May 2024 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7163426/
Lowe, D. (2020) Chloroquine, Past and Present. Science. Accessed May 2024 at https://www.science.org/content/blog-post/chloroquine-past-and-present
Ben-Zvi, I., Kivity, S., Langevitz, P., et al. (2012). Hydroxychloroquine: from malaria to autoimmunity. Clinical reviews in allergy & immunology, 42(2), 145–153. Accessed May 2024 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7091063/
Tanenbaum, L., Tuffanelli, D.L. (1980) Antimalarial Agents: Chloroquine, Hydroxychloroquine, and Quinacrine. Arch Dermatol. 116(5):587–591. Accessed May 2024 at doi:10.1001/archderm
NIH-National Institute of Arthritis and Muscoloskeletal and Skin Diseases. (Last reviewed October 22). Health Topics: Systemic Lupus Erythematosus (Lupus). Accessed May 2024 at https://www.niams.nih.gov/health-topics/lupus
McDaniel, B., Sukumaran, S., Koritala, T., et al. (Last updated 2023). Discoid Lupus Erythematosus. Continuing Education: StatPearls. Accessed May 2024 at https://www.ncbi.nlm.nih.gov/books/NBK493145/
Eastham, A.B., Vleugels, R.A. (2014) Cutaneous Lupus Erythematosus. JAMA Dermatol. 150(3):344. Accessed May 2024 at doi:10.1001/jamadermatol.2013.10393
Courville, C.J., Perry, E.T. (1953) Quinacrine (atabrine) in the Treatment of Lupus Erythematosus.AMA Arch Derm Syphilol.; 67(5):510–511. Accessed May 2024 at doi:10.1001/archderm.1953.01540050074015
Rhodes, B.L., Allende, M.F. (1953). Treatment of Chronic Discoid Lupus Erythematosus with Quinacrine. From the Department of Medicine, Subdepartment of Dermatology, University of California School of Medicine, San Francisco. Accessed May 2024 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1531780/pdf/califmed00290-0013.pdf
Rocchio, R., Kneeream, E., Shetty, D., et al. (2021) Regulatory History and Safety of Quinacrine HCI, 2021 FDA Science Forum. Accessed May 2024 at https://www.fda.gov/science-research/fda-science-forum/regulatory-history-and-safety-quinacrine-hc
FDA. (Content current as of December 2023). Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act. Accessed May 2024 at https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act
FDA. (Content current as of April 2023). Compounding Safety Information: Quinacrine Hydrochloride. Accessed May 2024 at https://www.fda.gov/drugs/human-drug-compounding/compounding-safety-information-quinacrine-hydrochloride

Advocate for Patients ACT Legislative Conference

Wed, 17 Apr 2024 22:49:16 GMT

by Amy Shank, PCCA Director of Government Affairs, and Claire Casey, PCCA Government and Public Affairs Specialist

Decision-makers who have met with compounding pharmacists in their districts and those who have toured a compounding pharmacy are more likely to understand the role of compounding in health care. To some, the compounding profession remains misunderstood. Compounders who tell their story — about their patients’ unique medical needs and their role and impact in the community — bridge this education gap.

The annual ACT Legislative Conference in Washington, D.C., is a key avenue for compounders to connect with their lawmaker and tell their story. Scheduled on May 14-15, 2024, registration remains open for PCCA member compounding pharmacists. Compounders will highlight two front-of-mind concerns.

Access to Compounded Hormones: Patients have relied on compounded hormones for decades when a manufactured product did not meet their medical need. This access is threatened due to recommendations by the National Academies of Sciences, Engineering and Medicine (NASEM)¹ that state commonly compounded hormones be considered for the FDA’s “difficult-to-compound” products list. If this proposal were fully implemented, patients from all backgrounds would face barriers in accessing therapies that include hormones such as progesterone, testosterone, estradiol and many more. Moreover, it would hinder prescribers and pharmacists from offering suitable treatment options to their patients when commercially available products don’t meet the patients’ needs.

A publication in Menopause² shows that there is more evidence available than what was identified and considered by the NASEM committee, and the evidence review process was not thorough — which casts doubt on these recommendations. Prescribers need all available treatment options for their patients.
Ensuring the Ability to Provide Informed Feedback to the FDA: Following enactment of the Drug Quality and Security Act (DQSA), the FDA has been utilizing guidance documents to enact regulatory framework. From prescription requirements for all human compounds to guidance on insanitary conditions at pharmacies, as well as guidance on medications compounded for animal patients — the FDA has used this guidance process to communicate regulatory directives, including guidelines used during the inspection process. Recently, the agency proposed to issue certain guidance documents “‘for immediate implementation’ without prior public participation.” This effectively eliminates the comment processes from guidance development — and may lead the FDA to implement policies that negatively impact patient safety, access to medical products and overall public health.

Pharmacists and pharmacy organizations want an avenue for meaningful dialogue and engagement with the agency, and maintaining an opportunity for a public comment period is critical to this effort. FDA should preserve and enhance its notice and comment process for guidance documents so they are appropriately informed by stakeholder insights and ultimately serve the best interests of public health. PCCA and compounders would like to be a continuing resource for all decision-makers. Our hope is for patient-centric policies that allow continued access to necessary and sometimes lifesaving compounded medications.

References

The National Academies of Sciences, Engineering and Medicine. (2020). The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Accessed April 2024 at https://nap.nationalacademies.org/resource/25791/cBHT%20Recommendations%20Insert.pdf
Liu, Y., Yuan, Y., Day, A.J., Zhang, W., John, P., Ng, D.J., Banov, D. (2022). Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. Menopause 29(4); 465-482. Accessed April 2024 at https://journals.lww.com/menopausejournal/fulltext/2022/04000/safety_and_efficacy_of_compounded_bioidentical.13.aspx

Best Practices for Promoting Compounded Preparations

Mon, 18 Mar 2024 16:12:31 GMT

Below, we outline key guidelines to help ensure your promotional efforts remain ethical, compliant and effective.

Guidelines for Promotional Content

Focus on Facts
We encourage members to share factual information about the technical aspects of compounded preparations and ingredients, supported by published articles, case studies and technical reports. Any use of patient testimonials should be focused on aspects of service, such as customer satisfaction, personalization of care or the professionalism of staff, rather than the effects of the compounded medication itself.
Communicating with Care
When discussing the effects of compounded preparations, it's essential to avoid claims about treating, curing or mitigating diseases unless backed by substantial evidence and in compliance with FDA guidelines. Similarly, steer clear of suggesting that a preparation is "safe" or "effective" for any condition. In all communications, prominently include the disclaimer: “The FDA does not review any compounded medication for safety or efficacy.”
Avoid Comparing Compounded Preparations to FDA-Approved Commercial Drugs
Avoid all direct comparisons between compounded medications and FDA-approved drugs in marketing materials. Instead, focus on the unique aspects of compounded medications, such as their ability to be tailored to meet individual patient needs when commercially available options are not suitable.

Our Commitment to Compliance

PCCA is committed to upholding the highest compliance standards with regulatory guidelines, recognizing the complexity of pharmaceutical compounding and marketing. These recommendations are a starting point; we strongly encourage engaging with legal counsel who specialize in FDA regulations and pharmacy law to regularly review your marketing materials. This proactive approach ensures your promotional efforts reflect the latest standards and practices.

USP 800: Is It Enforceable?

Wed, 10 Jan 2024 22:42:05 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Sections of the United States Pharmacopeia (USP) that don’t get enough attention are the General Notices. USP General Notices describe how the USP works. For example, this particular notice has shaped the applicability of USP 800:

“Applicable general chapters” means general chapters numbered below 1000 or above 2000 that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1000.¹

Until recently, USP 800 was an official chapter within USP but wasn’t considered “compendially applicable” because it wasn’t referenced in the General Notices, a monograph or another applicable general chapter numbered below 1000. However, on November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official. USP 795 and 797 are applicable general chapters that reference USP 800, which make USP 800 compendially applicable and potentially enforceable.

To determine if USP 800 is enforceable in your practice, you need to know which state or states your pharmacy is licensed in and know the related state board of pharmacy requirements. In my review of state regulations, more than 30 states have language generally requiring compliance with USP when compounding. This general language would require compliance with USP 795, 797 and 800.

Alternatively, some states are not allowed to adopt items by reference in their regulations. In other words, some states cannot simply say, “Follow USP,” but are required to write their own regulations. Some of those states write regulations that closely mirror USP chapters, but those state regulations may differ from USP. A few states have requirements that are more stringent than USP 795, 797 and 800. Other states are still considering USP 800 and will make their decisions at some point in the future. Several states have also delayed enforcement of USP 795, 797 and 800 for one to two years.

A few resources may help you understand where your state board of pharmacy is on these topics, such as state board of pharmacy websites, newsletters and the “law book” of each state. Calling a state board of pharmacy or inspectors for information — notably with mixed results — may produce a productive result. Another resource available to members of the Alliance for Pharmacy Compounding (APC) is their Compilation of State-Adopted USP 795, 797 and 800 Rules. Please note that use of this resource requires APC membership.

If you’ve researched the potential enforcement of USP 800 where your pharmacy is licensed and found that it’s not currently being enforced, you may think that nothing needs to be done when compounding hazardous drugs. However, the FDA does.

The FDA releases its thoughts on a variety of topics through what they call guidance documents. The preface in the agency’s Guidance for Industry, Insanitary Conditions at Compounding Facilities states:

This guidance represents the current thinking of the Food and Drug Administration (FDA or the Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

The guidance initially says that it’s not binding on the FDA or the public — which might make you think it’s not important — to the contrary, that guidance is a critical resource for understanding FDA’s thoughts and expectations during the agency’s inspections of compounding facilities, independent of whether or not any particular USP chapters are enforced by the state board of pharmacy. The guidance specifically calls out the handling of hazardous drugs, including sensitizing or highly potent drugs:

Handling bulk drug substances or drug products that are hazardous, sensitizing, or highly potent (e.g., hormones) with inadequate controls to prevent cross-contamination. This includes:

inadequate dedication, segregation, and containment (e.g., a powder-containment hood) of a suite, room, or piece of equipment based on risk;
inadequate cleaning of rooms, work surfaces, and equipment (e.g., utensils), including spills;
inadequate segregation of HVAC systems (as appropriate for the operation); and
inadequate control over the movement of personnel and materials.

Other federal agencies, including the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH), are involved in protecting compounding pharmacy staff from potential exposure to hazardous drugs.

USP 800 may or may not be enforced by your board or boards of pharmacy, despite being an official chapter that is now compendially applicable within the USP. Regardless of a board of pharmacy’s position, the FDA, OSHA and NIOSH are interested in preventing the potential for cross-contamination of hazardous, sensitizing and highly potent drugs on patients and compounding pharmacy staff.

The FDA rarely, if ever, references a USP chapter in inspection reports for compounding pharmacies. The state’s position on USP 800 does not affect the FDA’s approach to preventing insanitary conditions from existing in compounding facilities. Nor does the state’s position affect OSHA regulations.

Members with clinical services access may contact our Clinical Services team for help with compounding sterile and nonsterile formulations in compliance with USP Chapters 795, 797, 800 and the FDA’s Insanitary Conditions Guidance, as well as other compounding concerns.

References

United States Pharmacopeia. Online Subscription Required.

ThinkNext: International Seminar 2023

Wed, 08 Nov 2023 17:41:02 GMT

ThinkNext: ISTX23, the must-see compounding event held October 26-28 at The Woodlands Waterway Marriott, was our best International Seminar ever — until next year!

Day 1: Pearls from the Mainstage

ThinkNext: ISTX23 kicked off with a lively presentation from Peter Lovatt, PhD, also known as “Dr. Dance.” Dr. Lovatt discussed how structured and improvised movements affect brain functions, reviewed clinical studies on how structured dance movements positively impact people with Parkinson’s disease and, at the end of his presentation, encouraged the audience to participate in a structured dance routine.

PCCA Director of Research & Development Daniel Banov, RPh, MS, introduced our new base, EctoSeal P2G™ Powder, developed to transform wound care preparations at the tissue level. As Daniel discussed the benefits of the base’s natural ingredients, audience members received samples of EctoSeal P2G to see how it quickly transforms from powder to hydrogel and experience, firsthand, its protective film.

Our Member Pearls Panel started with Eddie DeCaria, RPh, FAPC, who presented ways to retain pharmacy staff and ensure they, as well as your pharmacy, thrive. Robyn Crow, RPh, followed with tips on dermatology compounding, and Jennifer Palazzolo, RPh, closed the session by discussing how point-of-care services can increase your pharmacy revenues.

After the Rx Runway Fashion Show lunch featuring 11 compounding colleagues sharing clinical compounding and business tips, participants heard from Sarah Zielsdorf, MD, MS, who shared her personal, “strenuous journey” on infertility during Part 1 of the Infertility Triad. Her pearl: “Test. Don’t guess.” Part 2 featured PCCA Director of Clinical Services Sara Hover, RPh, FAARM, who presented new infertility information, including endocrine disruptors, how mitochondria are involved in embryogenesis and nutrients that support mitochondria. Sara’s pearl: “Think of your patient’s’ hormone levels as a vital sign.” Part 3 of the triad featured a review of patient Margie Lamberth’s powerful story about her own infertility journey, which resulted in the birth of her son.

The final discussion of the day by our Regulatory Panel addressed topics ranging from GFI #256 to USP 800 implementation. The Regulatory Panel’s pearl: “Get involved. Get your patients involved. All of you are constituents.” Day 1 concluded with Ashley Berthelot of Professional Arts Pharmacy in Lafayette, Louisiana, receiving our 2023 L. David Sparks Advocacy award.

Watch the dance moves and see what you missed by clicking the video.

Day 2: Workshops Aplenty & Celebration

Rep. Morgan Griffith (R-VA) started the day sharing how two generations of his family were positively impacted by his local compounding pharmacy. Rep. Griffith later discussed why he introduced HR 167, the “Patient Access to Urgent-Use Pharmacy Compounding Act of 2023,” which in part addresses how compounders can help resolve drug shortages. His pearl: “Get to know your congressional members before issues arise.”

Participants later attended their choice of workshops from more than 15 options across five different tracks. For example, a Clinical & Formulations workshop offered “Top 10 Compounding Tips from the Lab”; a Marketing & Sales workshop presented “Do This, Not That: Making Claims and Images on Social Media”; and a Business & Development workshop discussed, “Pharmacy Talent Management: Nurturing the Best, Releasing the Rest.”

In between workshop sessions, participants enjoyed the Awards Luncheon, where we presented our 2023 M. George Webber Compounding Pharmacist of the Year award to Kevin Borg, PharmD, FAPC, FACA, owner of Potter’s House Apothecary in Peoria, Arizona, and Prescott Compounding Pharmacy in Prescott, Arizona. Our 2023 George Roentsch New Innovator award was also presented to Dayna Timmer, PharmD, owner of Mountainside Compounding in Tate, Georgia.

Day 2 ended with a party celebrating compounders and PCCA CEO David Sparks’ 80th birthday. Attendees dressed in their favorite 1950s attire, then danced, ate and partied like it was 1955!

Relive the fun or see what you missed in this short video.

Day 3: More Learning, Networking & Fun

The morning opened with functional medicine practitioner Mary Caire, MD, who covered “Emerging Therapies: Protocols for Low-Dose Naltrexone (LDN), Methylene Blue and Ivermectin.” During her presentation, Dr. Caire discussed how LDN tricks the brain into producing more endorphins. PCCA Clinical Compounding Pharmacist Sebastian Denison, RPh, FAARM (candidate), then tag-teamed Dr. Caire for a deeper dive into the chemical aspects of LDN, methylene blue and ivermectin, and ended his presentation by expressing his enthusiasm for how these emerging therapies may help patients.

Next, Holly Seyler, winner of our 2023 PCCA Institute Pharmacy Student Scholarship, treated participants to an enthusiastic presentation on “Speaking Loudly and Boldy for Our Patients” and thanked her compounding colleagues for their amazing support.

The day concluded with the return of Dr. Caire, whose presentation, “Libido is Your Life Drive,” explored the connection between libido, hormones and health, explaining how the libido is impacted by declining hormone levels, which

in turn may lead to declining health as we age.

Throughout the 3-day event, participants also enjoyed catching up with compounding colleagues, networking and enjoying the many activities of the new venue. We hope to see even more PCCA members, old and new, at ThinkNext: ISTX24 — our next “best international seminar ever!”

Catch a glimpse of what’s in store for ThinkNext: ISTX24.

Modular Compounding Cleanroom 101

Wed, 11 Oct 2023 15:48:05 GMT

Modular Compounding Cleanroom 101: Why would your pharmacy need one?

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services and Mike DeLisio, PCCA North American Sales Director

If you're thinking of integrating compounding services into your pharmacy, are new to compounding or are a seasoned professional who’s looking to expand, it's important to know regulatory standards are changing the compounding environment. Modular cleanrooms are a great way to implement or expand existing cleanrooms and address the ever-evolving compounding pharmacy regulations and standards. Advantages of choosing a modular compounding cleanroom include:

Lower operational costs
Greater customization & flexibility
Can be built adjacent to existing walls within pharmacy lab
Shorter build time
Easier to clean and maintain press53tg45lated to appropriate materials of construction
Less “down” time
Easier to supply air and exhaust air if required
Fewer disruptions for pharmacy & customers

What is a modular cleanroom?

Generally speaking, a modular cleanroom provides a dedicated space for compounding medicines within an enclosed environment. Its purpose is to help prevent compounded medications from potential contaminants and protect compounders from potentially harmful chemicals (hazardous materials) when appropriate controls are included in the design of the room. As such, a compounding cleanroom requires a well-sealed area using non-porous, powder coated materials that won’t harbor chemicals or microbes.

Modular cleanrooms are built using prefabricated materials. Given the increased regulatory focus on maintaining sanitary conditions in cleanroom environments, materials used in prefabricated constructions must be able to sustain routine exposure to harsh cleaning, sanitizing, decontaminating, or sporicidal solutions, which can easily degrade walls, doors, ceilings, and floors when they are not made from suitable materials.

Careful consideration should also be given to the cleanroom’s design, which directly impacts staff efficiency and efficacy of meeting cleaning standards. For example, walls, floors and ceilings designed with rounded or coved corners are much easier to clean than those with angular corners. Ceilings designed with a T-grid system with removable vinyl coated panels are easily sanitized and help safeguard against hidden microbes and other potential contaminants.

The type of compounding performed by your pharmacy will determine the types and levels of controls needed in the cleanroom:

A cleanroom used to compound non-sterile preparations (CNSP, USP 795) require the fewest controls;
A cleanroom used for CNSP using hazardous materials (USP 795 + USP 800) increases controls;
A cleanroom used to compound sterile preparations (CSP, USP 797) adds significant controls;
A cleanroom used for CSP using hazardous materials (USP 797 + USP 800) need maximum controls.

Additional Considerations

On November 1, 2022, the United States Pharmacopeia (USP) published revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations (CNSPs), will be official and possibly enforceable in your state on November 1, 2023. The date also triggers potential enforcement of USP 800, which addresses CNSPs and CSPs using hazardous drugs. USP 795 revisions define minimum schedules for cleaning and sanitizing nonsterile compounding area surfaces. Cleaning and sanitizing procedures also changed in Chapter 797 revisions, including environmental monitoring and cleaning processes for specific categories of compounded sterile preparations. The FDA also focuses on the quality of the compounding environment for both CNSPs and CSPs in their guidance, Insanitary Conditions at Compounding Facilities.

Cleanroom Providers

Given regulatory oversight and complexities, it’s vital to partner with an experienced and reputable cleanroom provider with:

Knowledge of regulatory & compounding industry standards
Recommendations to improve pharmacy workflow &minimize patient inconvenience
Experience in modular compound cleanroom installation for type(s) of compounding
Guidance and support throughout the build process
- Immediate notification of delays in cleanroom construction materials or build time
- Previous customer experience (i.e., testimonials, peer organizations, peer collaboration)
- Foremen and installation crews familiar with all wall-system components & trained from A to Z to install modular compounding cleanrooms

Initial Steps

Decide type(s) of compounding service(s) your pharmacy will offer (including lab expansion)
Become familiar with USP Minimum Standards
1. USP 795 sets minimum standards for non-sterile compounded preparations
2. USP 797 sets minimum standards for sterile compounded preparations
3. USP 800 sets minimum standards for compounding preparations with hazardous materials
Contact your state board of pharmacy to learn state board requirements
Become familiar with FDA guidance

Helpful Resources

PCCA partnered with ISO 9001 certified Nicos to deliver seamless cleanroom design with expert support that exceed USP minimum standards. Learn more here.

Watch our free webinar — Preparing for USP Compliance: What You Need & Need to Know — to learn how pending USP updates may impact cleanrooms in your state and pharmacy, as well as other relevant information.

PCCA offers additional resources to our members, including eLearning Compounding Training and multiple online webinars and training sessions. Members with clinical services access may also contact our Clinical Services team for help with formulas and other compounding concerns.

Oxytocin: Choosing the Right Chemical

Fri, 08 Sep 2023 14:48:15 GMT

by Catherine Henderson, PharmD, PCCA Clinical Compounding Pharmacist

As compounding pharmacists, we’re tasked with maintaining the highest levels of quality and safety in the medications we provide. It’s often challenging to meet the requirements of current rules and regulations while maintaining a profitable practice. The sourcing of our raw materials and active pharmaceutical ingredients (APIs) is an area where pharmacists must constantly evaluate cost and quality. Unfortunately, not all chemicals or chemical suppliers are created equal and therefore it’s necessary to create a component selection process for your pharmacy to ensure your chemicals meet current guidelines for use by the FDA.

The use of oxytocin as an API has risen in recent years due to emerging research about its usage for a variety of clinical applications. We wanted to shed some light on this chemical and use it as an example for creating API selection criteria in your pharmacy.

Oxytocin 101

Oxytocin is a natural human hormone that is secreted by the hypothalamus and stored in the pituitary gland. It has several FDA approved indications, with labor induction being the most common use. It is available commercially as oxytocin 10 Unit/mL solution for injection.¹

Oxytocin has also been studied for many off label uses as well, including intractable pain, autism, fibromyalgia, migraine, social anxiety, sexual dysfunction, weight loss and vaginal atrophy.^2-9 The most common dosage forms used in compounding are intranasal, sublingual and vaginal preparations.

It is important to note that oxytocin is sensitive to heat and should not be formulated in dosage forms such as rapid dissolve tablets or troches that require heat to make the final product.

Oxytocin Chemical Selection Criteria

At first glance, you may not think twice about choosing various oxytocin salts as an API. We are accustomed to seeing different salt forms of APIs. Lidocaine base vs. lidocaine HCl and dexamethasone vs. dexamethasone sodium phosphate are two common examples. In order to qualify an API for use in your pharmacy, there are several criteria you need to consider. Let’s take a look at oxytocin and one of its salts, oxytocin acetate, to see how these criteria apply.

In order to qualify for use as an API, the Federal Food, Drug and Cosmetic Act (FD&C Act) requires a chemical must meet ONE of the following qualifications:¹⁰

The API must be an active ingredient of an FDA approved product.
1. Oxytocin USP is the active ingredient in commercially available Pitocin®.¹¹
2. Oxytocin acetate is not an ingredient in an FDA approved product.
The API must have a USP monograph.
1. Oxytocin has a USP monograph.¹²
2. Oxytocin acetate does not have a USP monograph.
The API must be listed on the positive list of bulk drug substances for 503A or 503B pharmacies.^{13, 14}
1. Oxytocin doesn’t need to be listed here because it meets the previous criteria.
2. Oxytocin acetate is not found on either of these lists.

In the example above, you can see that oxytocin acetate doesn’t meet any of the eligibility requirements for compounding. Compounding with an unapproved API renders the medication to be adulterated under the FD&C Act and would reclassify the 503A pharmacy as a manufacturer that must follow Current Good Manufacturing (cGMP) guidelines.

Once you’ve determined if a chemical meets the criteria for eligibility for compounding, you must still evaluate the quality of that chemical using the Certificate of Analysis (COA) provided by your supplier. However, there is a misconception among some pharmacy professionals that a COA is the only item you need to scrutinize before approving a chemical.

By using the three criteria above and evaluating a COA, you will be on the right track to choosing the best APIs to use in your compounded preparations.

References

American College of Obstetrics and Gynecology (ACOG). (2009) ACOG Practice Bulletin Number 107: Clinical Management Guidelines for Obstetrician-Gynecologists. Induction of Laor. Washington, DC: American College of Obstetricians and Gynecologists.
Anderson, P. (2017) Unique Drug Combo Promising for Severe, Intractable Pain. Accessed September 2023 at https://www.medscape.com/viewarticle/887835#vp_2
Watanabe T, Kuroda M, Kuwabara H, et al. (2015) Clinical and neural effects of six-week administration of oxytocin on core symptoms of autism. Brain.;138:3400-3412. doi:10.1093/brain/awv249
Mameli S., Pisanu G.M., Sardo S., et al. (2014) Oxytocin nasal spray in fibromyalgic patients. Rheumatol Int. 34:1047–1052. doi:10.1007/s00296-014-2953-y
Anderson, P. (2013) Intranasal Oxytocin Looks Promising for Migraine. Accessed September 2023 at https://www.medscape.com/viewarticle/807277
Guastella A.J., Howard A.L., Dadds M.R., et al. (2009) A randomized controlled trial of intranasal oxytocin as an adjunct to exposure therapy for social anxiety disorder. Psychoneuroendocrinology. 34:917-23.
MacDonald K., Feifel D. (2012) Dramatic Improvement in Sexual Function Induced by Intranasal Oxytocin. J SexMed 9:1407–1410.
Zhang H., Wu C., Chen Q., et al. (2013)Treatment of obesity and diabetes using oxytocin or analogs in patients and mouse models. PLoS One. 8(5):e61477.
Jonasson, A. F., Edwall, L., & Uvnas-Moberg, K. (2011). Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause International. 17(4), 120-125.
Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Accessed September 2023 at https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Pitocin Package Insert. Accessed September 2023 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf
Oxytocin USP Monograph. Accessed August 2023 at https://online.uspnf.com/uspnf/document/1_GUID-19C2CA26-32EE-45C2-BF4E-A12A875B714B_1_en-US?source=Search%20Results&highlight=oxytocin
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug and Cosmetic Act. Accessed September 2023 at https://www.fda.gov/media/94155/download
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Accessed September 2023 at https://www.fda.gov/media/94164/download

Advocate for Compounding: The Power of Yet

Wed, 19 Apr 2023 11:00:00 GMT

by Kayla Valigura, PharmD candidate, University of Houston College of Pharmacy

I was incredibly honored to receive the 2022 Student Scholarship Award from PCCA Institute in October, as well as speak at PCCA’s International Seminar in front of so many devoted compounding pharmacists, technicians and support personnel. Now, I’m delighted to share portions of my speech and hope to motivate all compounders into acting on something near and dear to my heart.

Hooked on Compounding

Before applying to pharmacy school, I shadowed my hometown independent pharmacy. It’s there I first learned about compounding and first heard about PCCA. I was immediately hooked! I listened to calls the pharmacy technician made to PCCA’s Clinical Services team and was struck by their compassion, knowledge and reassurance.

After I applied and was accepted to the University of Houston College of Pharmacy, I was excited to learn that compounding was part of our first-year curriculum. Unfortunately, due to the pandemic, our labs were cut short, and we were left with rapid-fire compounding techniques that made us sweat through our PPE.

As some may recall, it’s easy to lose sight of the big dreams and aspirations you had when you started pharmacy school. I began feeling like my life was an endless study session, a continuous loop of lecture recordings. I began wondering why I applied to pharmacy school in the first place, until I stepped foot into PCCA for the Advanced Compounding Lab. I enjoyed my compounding labs at UH, but learning more about compounding in the PCCA environment really opened my eyes. I don’t recall what my expectations were but I do know PCCA far exceeded all of them. I can honestly say I had more fun and felt more passion for the field in those two days than I had during my first two years in pharmacy school. And with two years of pharmacy school behind me, all of the light bulbs started to go off and everything made sense. I knew exactly where I was supposed to be.

After having this monumental realization, I was bursting at the seams with excitement. And I was telling anyone who listened all about compounding. I quickly noticed, however, that many people had never heard of compounding, let alone personalized medicine.

Honestly, at first I felt a bit disheartened. I have so much passion for our profession, but there was such a lack of recognition for it. However, it didn't take me long to figure out that the solution was right there in the problem. The way I see it, that lack of recognition leaves everything open-ended.

Compounding: It’s Truly Personal

I believe that our profession is synonymous with the “power of yet.” In other words, it hasn't been done yet. There really is no limit to what we can accomplish and who we can help. And I am ready to be a part of these discoveries. To be more specific, I'd like to see more changes and research in mental health treatment options.

Suicide rates are higher than they've ever been, and everywhere you turn, there are posters about how to better manage your mental health. There is so much talk about patients with mental health disorders, but where is the action?

I have generalized anxiety disorder and have tried my fair share of antidepressants. So I speak from personal experience, as well as with empathy and compassion for thousands of individuals when I say the current pharmacological treatment options for mental health disorders are subpar at best. Most of the time, the only option for patients is to try several antidepressants until they find one that has the least amount of side effects. This doesn't sound so bad until you consider that most of these medications take about a month or so to reach full benefit — not to mention that many can significantly worsen a patient's condition.

This can be an incredibly exhausting process, and most of the time patients will give up entirely and stop seeking treatment. There just has to be a better way.

I firmly believe that mental health treatments need to shift away from trying to fit a patient to a medication and move toward fitting a medication to an individual patient. I believe compounding could play a major role in mental health treatments because it offers a uniquely personalized option developed exclusively for one person.

Now Is the Time to ACT

The time is now because patients need our help. And although my heart absolutely breaks for all of the individuals who we couldn’t help, I am incredibly hopeful at the possibility of transforming mental health treatments in the future and ensuring the rights of patients who use compounded preparations today.

Like many of you, I have an unwavering passion for people. I live and breathe to help others and constantly look for ways to help those in need. I truly am an advocate for the people, and right now the people need me. The compounding profession needs me. And I need you.

I need you to join me in actively advocating for our profession. We can collectively raise our voices to state legislators and congressional members who hold the authority to help us positively impact the lives of individuals who needlessly suffer. I urge you — especially those who compound for HRT patients — to join me on May 16-17 at the 11^th Annual ACT Legislative Conference in Washington, D.C. Together, we can transform the “power of yet” into the “power of now” and reduce the limits on what we can achieve and who we can help.

As the recipient of PCCA Institute’s 2022 Student Scholarship Award, Kayla will accompany the PCCA Public Affairs team during the 11^th Annual ACT Legislative Conference in Washington, D.C., on May 16-17. Please join us in advocating for compounding pharmacies and register now.

Top 5 Things to Know About GFI 256

Wed, 29 Mar 2023 12:11:48 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Federal law does not address compounding from bulk drug substances, also known as active ingredients, for animals like it does for people through Section 503A of the Food, Drug and Cosmetic Act. Due to this distinction, FDA created a framework for what they believe is appropriate when compounding for animals using active ingredients and, if this framework is followed, they will not take enforcement action against the compounder for serving the needs of their animal patients.

FDA describes their framework for animal compounds in Guidance for Industry #256, Compounding For Animals From Bulk Drug Substances. It is imperative that you read the full guidance document and other resources to ensure compliance. To get you started, here are the top five things you need to know about patient-specific animal compounds.

FDA expects that manufactured drug products, including animal or human drugs, will be used for animals when they are appropriate for their care. If an FDA-approved, conditionally-approved or indexed drug can be used to treat the animal, then it is supposed to be used.
FDA is concerned about compounded copies of manufactured drug products for animals. GFI 256 states that a copy occurs for an animal when the compound has the same active moiety (erythromycin, erythromycin stearate, erythromycin ethylsuccinate are all the same in the eyes of GFI 256) and the same route of administration. This means that a compounded suspension of the same active ingredient in a manufactured tablet could be a copy. If your compound could be considered a copy, then you need a documented reason why the compound was necessary, such as the animal could not be pilled. GFI 256 provides other examples.
If you are going to compound any preparation for an animal, FDA expects that you will determine if you can compound that dosage form from a manufactured drug product. If you determine that you cannot compound that medication from a manufactured product, then you need to document the rationale. GFI 256 provides examples.
Ingredient quality matters. FDA’s GFI expects you to use a USP- or NF-grade chemical when a monograph exists. Notably, water has a USP monograph. You need to use Purified Water USP or a better grade of water (i.e., sterile water for irrigation, sterile water for injection). Please note that grocery store water products labeled as purified water are not Purified Water USP.
GFI 256 also points out that like all drugs, animal drugs cannot be produced under insanitary conditions. It is paramount that you stay vigilant to avoid the types of examples FDA has provided in the Insanitary Guidance Document.

These are our top 5 things for you to know about GFI 256 and patient-specific animal compounds. However, there are many more valuable details and nuances provided through a variety of resources, including: FDA’s own FAQ; a letter from FDA to APC and NCPA that answered their questions; and many others. Links to these resources are listed below. If you’d like a deeper explanation, please see the GFI 256 webinar produced by PCCA in collaboration with Alliance for Pharmacy Compounding. This webinar recording is on sale through June 15, 2023. PCCA members with access to clinical services can contact the Clinical Services team of pharmacists to discuss their questions.

FDA plans to start using the framework in GFI 256 starting April 1, 2023, through a phased-in process. For those who compound for animal patients, now is the time to make decisions regarding how you utilize GFI 256.

Resources

USP 797: Revisions & Impacts, Part 2

Wed, 08 Mar 2023 12:00:00 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

If you missed Part 1 of USP 797: Revisions & Impacts, it can be found here.

ENVIRONMENTAL MONITORING

Personnel compounding Category 3 sterile preparations are required to perform media fills with glove fingertip sampling and surface sampling of the direct compounding area at least every three months, compared to at least every six months for those compounding Category 1 or 2 sterile preparations.

Pharmacies compounding Category 3 sterile preparations also require more frequent monitoring. Thirty days prior to starting to compound any Category 3 batches, viable air sampling must be conducted. Viable air sampling using an impaction device must be completed for each classified area monthly for facilities preparing Category 3 sterile preparations, compared to every six months for facilities preparing Category 1 or 2 preparations.

Surface sampling is required weekly for Category 3 sterile preparations and must be performed in the ISO 5 with each batch of a Category 3 CSP unless using a self-enclosed robotic device. By contrast, for Category 1 or Category 2 preparations, surface sampling is required monthly. Surface sampling must be done in all classified areas and pass-throughs. The sampling must include:

Each classified area, including each room
The interior of each ISO Class 5 primary engineering control (PEC)
Pass-through chambers connecting to classified areas
Equipment contained within the PEC
Staging or work area(s) near the PEC
Frequently touched surfaces

Pharmacies must also conduct viable air sampling and surface sampling:

When new facilities and equipment are certified
After servicing any facility or equipment (see Section 4, Facilities and Engineering Controls)
After identifying any problem (e.g., microbial growth in preparation sterility tests)
After identifying any problematic trends (e.g., failed fingertip/thumb sampling results, failed media-fill testing, or repeated air or surface contamination)
Any changes are made to the facility or processes that could impact the compounding environment (e.g., change in cleaning agents)

Pharmacies must also conduct total airborne particle-count testing in all classified areas during dynamic operating conditions at least every six months for all categories of sterile preparations.

CLEANING AND SANITIZING

Cleaning and sanitizing procedures also changed in Chapter 797 revisions. Pharmacies must clean surfaces prior to disinfecting them unless they use EPA-registered (or equivalent outside the U.S.) one-step disinfectant cleaners that simultaneously clean and disinfect with an appropriate contact time specified by the product.

In a PEC, after cleaning and disinfecting, pharmacies must apply sterile 70% isopropyl alcohol (IPA) to remove any residues of the product(s). Sterile 70% IPA must also be applied immediately before initiating compounding.

Another significant difference exists in the frequency of sporicidal application between Categories 1 and 2 and Category 3 preparations. When pharmacies create Category 3 preparations, they must apply a sporicidal agent to the PEC, including the removable work tray (if applicable), the equipment and work surfaces outside the PEC (pass-throughs and floors) at least weekly. Compounding Categories 1 and 2 preparations require monthly application of a sporicidal agent to all areas.

Along with these changes, the process for cleaning and disinfecting the PEC received more detailed directions. Compounders must:

If necessary, remove visible particles, debris or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers.
Use a sterile low-lint wiper, apply a sterile cleaning agent followed by a sterile EPA-registered disinfectant, or apply a sterile EPA-registered (or equivalent for entities outside the U.S.) one-step disinfectant cleaner to equipment and all PEC interior surfaces.
Ensure the contact time specified by the manufacturer is achieved.
Use a sterile low-lint wiper, apply sterile 70% IPA to equipment and all PEC interior surfaces.
Allow the surface to dry completely before beginning compounding.

WHAT COMES NEXT

USP 795 and 797 are official and possibly enforceable in your state on November 1, 2023. Revisions to USP 795 and 797 also make USP Chapter 800, Hazardous Drugs — Handling in Healthcare Settings, “compendially applicable” (USP term) and possibly enforceable in many states on November 1, 2023. For more information on Chapter 800, visit pccarx/USP Update/800.

PCCA offers resources to help pharmacies navigate the changing compounding standards and regulatory environment, including our blog on FDA Insanitary Conditions and limited USP training courses at eLearning Compounding Training.

PCCA offers additional resources to our members, including all courses offered in our eLearning Compounding Training, multiple online webinars and training sessions and, for members with Clinical Services, Speakers Bureau to guide, assist and educate compounding pharmacy staff. Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

USP 797: Revisions & Impacts, Part 1

Wed, 01 Mar 2023 12:00:00 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

USP 797 Revisions

USP offers a number of tools for USP 797 revisions, including:

USP 797 FAQs
USP 797 Commentary
USP 797 Open Forum Presentation presented and recorded on November 8, 2022
USP 797 Open Forum Slides presented on November 8, 2022

CSP Categories

Category 1 CSPs are compounded under the least controlled environmental conditions and assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated (see USP 797 revisions for additional requirements). Category 2 CSPs require more environmental controls and testing and may be assigned a BUD of greater than 12 hours at controlled room temperature or more than 24 hours if refrigerated. Category 2 CSP formulations may not exceed BUD limits established in Table 13 of 797 revisions.

Revisions to USP 797 contain Category 3 CSPs, which offer longer possible BUDs compared to Category 1 and Category 2 CSPs. Category 3 BUDs are found in Table 14 of the revised Chapter 797 (see below).

TABLE 14. BUD LIMITS FOR CATEGORY 3 CSPs
Compounding Method	Controlled Room Temp. (20 – 25^oC)	Refrigerated (2 – 8^oC)	Freezer(-25 – -10^oC)
Aseptically processed, sterility tested and passing all applicable tests for Category 3 CSPs	60 days	90 days	120 days
Terminally sterilized, sterility tested and passing all applicable tests for Category 3 CSPS	90 days	120 days	180 days

Category 3 CSPs have a number of additional requirements. For example, Category 3 CSPs must be supported by a stability-indicating assay validated using USP 1225, Validation of Compendial Procedures. The sterile preparation must follow the same ingredients and procedures as the stability assay, as well as packaged using the exact container-closure system and made of the same materials used in the study.

Category 3 CSPs, such as injectables or ophthalmic solutions, must pass the appropriate particulate matter test once for each formulation. Injections must pass particulate testing according to USP 788, Particulate Matter in Injections, while ophthalmic solutions must pass particulate testing according to USP 789, Particulate Matter in Ophthalmic Solutions. Additionally, the container-closure systems used for injections and ophthalmic solutions must pass testing according to USP 1207, Package Integrity Evaluation — Sterile Products, for each formulation. Both Category 2 and Category 3 multidose CSPs must pass antimicrobial effectiveness testing in accordance with USP 51.

ENDOTOXIN TESTING

Category 1 sterile preparations do not require endotoxin testing. Category 2 sterile injectable preparations compounded from one or more nonsterile components and assigned a BUD that requires sterility testing must be tested for endotoxin content in accordance with USP 85, Bacterial Endotoxins. If a Category 2 sterile preparation is compounded from one or more nonsterile components but is assigned a BUD that does not require sterility testing, endotoxin testing is not required; however, endotoxin testing is suggested. Category 3 sterile injectable preparations compounded from one or more nonsterile component(s) must be tested for endotoxin content.

GARBING PRACTICES

Beyond the data and test(s) supporting the formulation, additional requirements exist in the revisions to 797 for everyone entering a buffer room where Category 3 CSPs are prepared. Anyone entering a buffer room where Category 3 CSPs are prepared must follow stricter garbing practices:

Compounders are not allowed any exposed skin in the buffer room (e.g., face and neck must be covered).
All low-lint outer garb must be sterile, including the use of sterile sleeves over gauntlet sleeves when restricted access barrier system (RABS is used.
Once a compounder leaves a classified area, disposable garbing items must be discarded and laundered garb must not be reused without being laundered and re-sterilized with a validated cycle.
The facility’s SOPs must describe disinfection procedures for reusing goggles, respirators and other reusable equipment.

PCCA offers resources to help pharmacies navigate the changing compounding standards and regulatory environment, including our blog on FDA Insanitary Conditionsand limited USP training courses at eLearning Compounding Training.

Part 2 of USP 797: Revisions & Impacts, can be found here.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

USP 795: Revisions & Impacts, Part 2

Wed, 15 Feb 2023 13:30:23 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

If you missed Part 1 of our USP 795: Revisions & Impacts, it can be found here.

Beyond Use Dates

The concept of water activity receives significant discussion in the revisions to 795. Water activity is a measure of the water that is unbound and freely available to participate in chemical, biochemical or physicochemical reactions, or provides an environment that supports microbial growth. Compounded preparations with a water activity less than 0.6 are considered anhydrous with extended BUDs because they are less likely to allow degradation of API or microbial growth. Discussions on water activity were expanded in 795 revisions and examples of the water activity of various dosage forms were added to the chapter (USP 1112 also discusses water activity).

The maximum potential BUDs that can be assigned to compounded nonsterile preparations without additional stability testing has changed. Nonaqueous topicals, suppositories and troches are now preparations that allow up to 180-day expanded BUDs. Nonaqueous oral preparations can be assigned up to a 90-day BUD. Aqueous dosage forms are separated based on whether or not they have a preservative: non-preserved aqueous dosage forms may be given up to a 14-day BUD when stored at refrigerated temperature; preserved aqueous dosage forms may be given up to a 35-day BUD at room temperature or under refrigeration.

BUDs may extend up to 180 days with a stability study (published or unpublished) using a stability-indicating assay for the API(s), CNSP and type(s) of container closure used. If the BUD of an aqueous preparation is extended, the formulation must also be tested for the performance of the preservative, known as antimicrobial effectiveness testing, according to USP Chapter 51. Revisions to Chapter 795 also permit use of bracketing for stability studies and antimicrobial effectiveness testing. Bracketing is performing tests on a low concentration and a high concentration of API(s). If the formulation passes the tests at both concentrations, the data can be applied to all strengths that fall between the two that were tested.

PCCA has developed over 200 FormulaPlus^™ formulas tested with stability-indicating assays and USP 51 antimicrobial effectiveness (when applicable) for extended BUDs. Some of these are bracketed formulations to help PCCA members address the variety of strengths prescribed by practitioners. FormulaPlus^™ formulas meet all requirements in USP 795 revisions.

THE DESIGNATED PERSON(S)

Responsibility for the performance of the compounding operation created a new role, called the “designated person(s) (DP),” which holds one or more people responsible and accountable for the performance and operation of the facility and personnel preparing CNSPs. The DP(s) is tasked with over 20 areas of responsibility. Note a pharmacy can have one or several persons as the designated person(s), hence the “(s).” These responsibilities can therefore be divided among team members who are appropriate for each responsibility. A few DP(s) key responsibilities are training, documentation and quality control/assurance. While training was discussed above, it is imperative to highlight documentation, including:

Personnel training, competency assessments and qualification records, with corrective actions for any failures
Equipment records (e.g., calibration, verification and maintenance reports)
Certificates of analysis and all documentation required for components not conventionally manufactured
Receipt of components
Standard operating procedures, master formulation records and compounding records
Release-inspection and testing records
Information related to complaints and adverse events, including corrective actions taken
Results of investigations and corrective actions
Records of cleaning and sanitizing the designated compounding area
Temperature logs
Accommodations to personnel compounding CNSPs
Any required routine review (e.g., yearly review of quality assurance and quality control programs, yearly review of chemical hazard and disposal information)

USP 795 references USP 1163 on quality assurance, which can be a helpful resource in developing the required formal written quality assurance and quality control program. This program should establish a system of:

Adherence to procedures
Prevention and detection of errors and other quality problems
Evaluation of complaints and adverse events
Appropriate investigations and corrective actions, such as:

Determining when recalls must be initiated, including procedures to immediately notify the prescriber of a failure of specifications with the potential to cause patient harm (e.g., strength, purity or other quality attributes)
Determining the distribution of any affected CNSP, including other affected lots, and the date and quantity of distribution
Identifying patients who received the CNSP
Recalling any unused dispensed stock and quarantining any remaining stock
Disposing of the recalled CNSP and documentation

PCCA offers additional resources to our members, including all courses offered in our eLearning Compounding Training , multiple online webinars and training sessions and, for members with Clinical Services, Speakers Bureau to guide, assist and educate compounding pharmacy staff. Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

Look for USP 797: Revisions & Impacts, Part 1 Blog, on March 1.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

USP 795: Revisions & Impacts, Part 1

Mon, 06 Feb 2023 14:33:14 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

On November 1, 2022, the United States Pharmacopeia (USP) published revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations (CNSPs), which becomes official and possibly enforceable in your state on November 1, 2023. The date also triggers potential enforcement of USP 800, which addresses CNSPs using hazardous drugs.

For access to USP 795 revisions, USP offers two purchase options: the USP Compounding Compendium or the full USP-NF. Purchase of the USP Compounding Compendium grants access to more than 40 USP General Chapters, including 795, 797 and 800. Although purchase of the full USP-NF costs more, access includes USP chemical and product monographs, which are useful in determining how to use data from certificates of analysis.

USP 795 Revisions

USP offers a number of tools, including:

USP 795 FAQs
USP 795 Commentary
USP 795 Open Forum Presentation presented and recorded on November 8, 2022
USP 795 Open Forum Slides presented on November 8, 2022
Adding Flavor to Conventionally Manufactured Nonsterile Products

Training

Revisions to USP 795 emphasize certain subtopics: specifically, a significant expansion and emphasis on training, including knowledge in and demonstration of core competencies. A trainee must show their ability to read and understand concepts and demonstrate their knowledge and ability to perform tasks, with documentation of all trainings and demonstrations.

Core competencies include:

Hand hygiene
Garbing
Cleaning and sanitizing
Handling and transporting components and CNSPs
Measuring and mixing
Proper use of equipment and devices selected to compound CNSPs
Documentation of the compounding process (described in Section 7 of the chapter, Master Formulation and Compounding Records)

In addition, training must include:

Ability to understand USP 795 requirements
Ability to understand and interpret safety data sheets (SDSs) and, if applicable, certificates of analysis (COAs)
Read and understand procedures related to their compounding duties

Hand hygiene, garbing, cleaning and sanitizing are cited as significant core competencies for nonsterile compounding. While some may consider the purpose of garbing and personal protective equipment (PPE) is to protect compounders, the garbing process and PPE are significant tools that reduce skin cells shed and the microbes they can carry from potentially contaminating the compounded medication. In other words, properly donned PPE protects the compounder from chemicals and protects the compounded medication from potential contamination.

Cleaning and Sanitizing

Table 1 in the USP 795 revisions define minimum schedules for cleaning and sanitizing nonsterile compounding area surfaces. USP has multiple chapters on microbial limits for nonsterile preparations, including USP 61 and USP 62. These chapters contain total microbial contamination limits and specific objectionable microorganisms prohibited in nonsterile compounds. The FDA also focuses on the quality of the compounding environment for CNSPs in their guidance, Insanitary Conditions at Compounding Facilities.

Beyond-Use Dates

Beyond-use dates (BUDs) are always of significant interest to compounders because they affect patient care opportunities. When considering BUDs, it is common to look at the chemical and physical properties of an active pharmaceutical ingredient (API). The revisions to USP 795 also focus on the container closure system used for final formulations, including how the container closure may interact with CNSP API(s). Visually inspecting the integrity of the container closure after packaging and prior to release, as well as considering the possible container closure degradation over time, are all valuable. The integrity of the container closure is important because an improperly sealed, cracked or degraded container closure can potentially lead to microbial contamination or a loss of potency.

Part 2 of USP 795: Revisions & Impacts can be found here.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

The 2021 FDA PCAC Meeting, Methylcobalamin and a Request for Help

Wed, 24 Nov 2021 20:19:06 GMT

By A.J. Day, PharmD, PCCA Vice President of Clinical Services

When I made a decision to become a pharmacist, it was because I wanted to help people. Pharmacy compounding fulfilled that desire because it serves as the perfect balance between medicine, the practical application of chemistry and service to our communities. Nowhere in that picture did I imagine directly interacting with policymakers, boards of pharmacy and the FDA. However, I quickly learned that my ability to be a compounding pharmacist was dependent on decisions made by people who do not have expertise in compounding, so I either needed to find somebody to listen to me whine about it, or I needed to get involved. Due to a lack of friends with sympathetic ears, and a wife who already had to listen to me whining about other things, my only option was to get involved. One of the ways I’ve done this is by participating in FDA Pharmacy Compounding Advisory Committee (PCAC) meetings.

How the PCAC Process Works

When Congress passed the Drug Quality and Security Act (DQSA) in 2013, the FDA went to work implementing the law. It defines the qualifying factors for a substance to be used as an active pharmaceutical ingredient (API) in a human compounded preparation. If a substance does not have an applicable USP-NF monograph and it is not an API in an FDA-approved drug product, there is still a pathway to make it eligible for use in compounding: The FDA has to convene a PCAC meeting, and one of that committee’s duties is to make recommendations to the FDA on whether or not chemicals can be used as APIs in human compounding. The final list that the FDA creates is sometimes called the “positive list.” Interested parties can submit nominations to the FDA, and if the nominations provide sufficient information for the administration to review, then they will be discussed and voted on at a PCAC meeting. Importantly, the committee votes are just an advisory recommendation, and the FDA is not obligated to heed that advice.

There have been 10 PCAC meetings since the passage of the DQSA, and I have attended all of them (I have presented at nearly all of them, too). The meetings follow a set format:

The FDA presents their perspective on the nominated substance (for or against adding it to the positive list, and all the assessments they performed to come to that decision)
The PCAC can ask them clarifying questions
The nominator presents why they feel the item should be added to the positive list
The PCAC can ask them clarifying questions
There is an opportunity for members of the public (who preregister) to speak about the substance
The PCAC will then discuss the substance further and vote

Then the process repeats for the next items on the agenda.

Methylcobalamin and the 2021 PCAC Meeting

It is quite rare for the PCAC to vote against the FDA’s recommendation — it has happened for only five of the 57 substances reviewed. The most recent of these was on June 9, 2021, regarding the use of methylcobalamin. Multiple organizations nominated methylcobalamin and for a variety of uses. PCCA’s nomination focused on its use for patients with autism spectrum disorder (ASD). When the FDA announced the meeting and contacted all nominators about presenting, the other groups all declined to defend their nominations. I think it is vital that compounders are seen as reputable and professional, and defending our nominations is important for the reputation of our industry.

Having said that, their withdrawal from the meeting meant that I had more time for my presentation to the PCAC and the FDA, and I could keep the conversation focused on patients with ASD. I had help from Dr. Richard Frye, a physician and researcher specializing in neurodevelopment and ASD. He has a private practice and is an attending physician at Phoenix Children’s Hospital in Arizona. Dr. James Neubrander, who has a private practice in New Jersey and credits himself with bringing methylcobalamin injections to the treatment toolbox for ASD in 2003, also shared his knowledge. I have been working with both of these physicians, and others, since 2017 to provide data to the FDA. For the PCAC meeting, Dr. Neubrander was selected as a speaker for the open public hearing session. Therefore, I decided to give some of my speaking time to Dr. Frye so that the PCAC would also hear his expert testimony.

There was lots of discussion about potential risks, dosing, clinical assessment and stability of the specific formulation we nominated. Heaps of credit are due to PCCA’s Research and Development and Formulation Development teams for the robust testing they performed to validate the formulation as well as its stability, and to the PCCA Science team for getting all of that published in a peer-reviewed journal. The published stability data was cited by the FDA, and it is due to this peer-reviewed article that the FDA felt confident that compounders could make the formulation within the parameters of USP Chapter 797. We were able to secure a 9–5 PCAC vote in favor of adding methylcobalamin to the positive list (the FDA had recommended to the PCAC that it not be included on the positive list). This tale is far from over, and much still needs to be done.

Key Takeaways and Next Steps

The FDA still needs to make a final decision on methylcobalamin. The PCAC vote is just the vote of an advisory committee making a recommendation to the agency, and the FDA can decide not to include methylcobalamin on the final positive list.
Methylcobalamin, as an API for compounding, still must comply with the other requirements for DQSA Section 503A. Notably, it must be produced by a manufacturer that registers it as a drug with the FDA. PCCA’s methylcobalamin meets these and the extra requirements of The PCCA Standard™.
If you are compounding with methylcobalamin for patients with ASD, we need your help. We need to work with researchers and practitioners, like Dr. Frye and Dr. Neubrander, to publish more data to provide evidence of safety and efficacy. We need to work on this now and get it published in peer-reviewed journals soon so that the FDA may consider it before making a final decision on the fate of methylcobalamin. Please contact me to discuss how we can work on this!

We are grateful to all the PCCA members who provided assistance in the lead-up to the June 9 methylcobalamin discussion, and to Dr. Frye and Dr. Neubrander. Dr. Dan Rossignol was not on the agenda for the PCAC meeting, but his work was also vital to our success.

Our goal in this advocacy work is to protect patient access to customized therapy so that compounding pharmacies can help the people in their communities. My colleagues here at PCCA and I look forward to many more years of serving PCCA member pharmacies and their needs.

A.J. Day, PharmD, is the Vice President of Clinical Services at PCCA. His focus areas include pediatric compounding, veterinary compounding, pain management, regulatory compliance and compounding technique. A.J. has provided CE and non-CE presentations to thousands of physicians, veterinarians and pharmacists around the world. He has provided expert testimony to the FDA on behalf of the compounding profession on multiple occasions. A.J. is active with the Alliance for Pharmacy Compounding, currently serving on their Board of Directors; the National Community Pharmacists Association, currently serving on their Committee on Compounding; the Society of Veterinary Hospital Pharmacists; and several other pharmacy groups.

A version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

Urgent-Use Compounding Legislation Introduced in Congress

Wed, 27 Oct 2021 13:37:47 GMT

By Amy Shank, PCCA Director of Government Relations

In June 2021, Congressmen Henry Cuellar, D-TX, and Morgan Griffith, R-VA, introduced H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021. If enacted, this proposal will ensure critical patient access to urgently needed medications as well as ensure that pharmacies can continue to assist with drug shortages.

When the Food and Drug Administration (FDA) published its 2020 guidance document that temporarily expanded what medications 503A pharmacies can compound as well as the circumstances when they can compound them, the FDA acknowledged that urgent patient need should outweigh prescription requirements for 503A compounding, provided that other safeguards are in place. H.R. 3662 is in line with this guidance document and strikes that critical balance.

It Helps Compounders Meet Urgent Patient Needs

A delay in providing medication can result in patient harm, and the requirement for a patient-specific prescription for an urgent patient need may hamper care. For instance, certain patients may need antibacterial, antifungal or antiviral compounded medications to treat eye infections in immediate if not emergent circumstances.

To address these concerns, the legislation waives the patient-specific prescription requirement and allows a licensed provider to administer compounded medications to human patients in a clinical setting, provided that patient information be paired with the prescription within seven days of administration or seven days of patient discharge. This would only be allowable if four criteria are met:

The prescriber certifies that the medication is not otherwise available.
The medication is compounded in a limited quantity.
The medication is assigned an appropriate beyond-use date.
Adverse events are reported.

It Helps Compounders Assist With Drug Shortages

During the COVID-19 pandemic, the FDA used enforcement discretion for compounding drugs with respect to the “essentially a copy” requirements, as outlined in the temporary guidance document mentioned above. Thus, if a drug was in shortage, 503A pharmacies and 503B outsourcing facilities could produce the drug in shortage, and the FDA would not enforce statutory requirements that compounded drugs cannot be essentially a copy of a commercially available product.

H.R. 3662 would codify that flexibility while also providing safeguards to protect patients from further drug shortages. It would accomplish this by expanding the shortage definition to include the FDA’s list of drug shortages as well as shortages identified by the American Society of Health-System Pharmacists (ASHP), given that ASHP’s list encompasses a larger number of drug products on shortage and not only those that are deemed medically necessary.

You can read H.R. 3662 online as well as the FDA’s 2020 temporary compounding guidance document and the FDA’s “essentially a copy” guidance document . PCCA members can contact our Public Affairs team with any questions they may have about this bill.

Also on The PCCA Blog: How to Cultivate a Relationship With Your Lawmakers

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group, where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip office as a policy advisor.

A version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

THE PCCA BLOG

We’re Raising the Bar on Quality: PCCA Becomes First to Earn USP Verification for Compounding Bases

Why USP Verification Matters

A Closer Look at Our USP Verified Excipient Bases

Proactive, Not Reactive

What This Means for You

Best Practices for Marketing

Adhere to Legal and Regulatory Requirements for Compounding

Avoid Unsubstantiated Claims

Conduct Thorough Marketing Reviews

Resources: Best Practices for Marketing

Hazardous Drug Wipe Sampling: Do I have to?

What and where should I test?

What do I do with the sampling results?

Reference

The Best Jam Compounding Fest in the Land — Until Next Year!

Clinical Presentations

Innovation

Marketing

Revenue Generation

Regulatory Concerns

Award-Winning Members

USP Chapter 800: Managing HD Spills

Spill Control

Spill Kits

Spill Drills

References

The Storied Past of Quinacrine HCI

Quinacrine HCI: First Use in Lupus Treatment

DQSA Regulation

FDA Acceptance

References

Advocate for Patients ACT Legislative Conference

References

Best Practices for Promoting Compounded Preparations

Guidelines for Promotional Content

Our Commitment to Compliance

USP 800: Is It Enforceable?

References

ThinkNext: International Seminar 2023

Day 1: Pearls from the Mainstage

Day 2: Workshops Aplenty & Celebration

Day 3: More Learning, Networking & Fun

Modular Compounding Cleanroom 101

Modular Compounding Cleanroom 101: Why would your pharmacy need one?

What is a modular cleanroom?

Additional Considerations

Cleanroom Providers

Initial Steps

Helpful Resources

Oxytocin: Choosing the Right Chemical

Oxytocin 101

Oxytocin Chemical Selection Criteria

References

Advocate for Compounding: The Power of Yet

Hooked on Compounding

Compounding: It’s Truly Personal

Now Is the Time to ACT

Top 5 Things to Know About GFI 256

Resources

USP 797: Revisions & Impacts, Part 2

ENVIRONMENTAL MONITORING

CLEANING AND SANITIZING

WHAT COMES NEXT

USP 797: Revisions & Impacts, Part 1

USP 797 Revisions

CSP Categories

ENDOTOXIN TESTING

GARBING PRACTICES

USP 795: Revisions & Impacts, Part 2

Beyond Use Dates

THE DESIGNATED PERSON(S)

USP 795: Revisions & Impacts, Part 1

USP 795 Revisions

Training

Cleaning and Sanitizing

Beyond-Use Dates

The 2021 FDA PCAC Meeting, Methylcobalamin and a Request for Help

How the PCAC Process Works

Methylcobalamin and the 2021 PCAC Meeting